The administrative order is issued to establish the new schedule of fees and charges for services rendered by the FDA and to provide guidelines for its implementation. The new fee
Regulatory News
Thai FDA published new guidelines on labelling requirements for medical devices
Thai FDA published new guidelines on labelling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for both home use and
Thai FDA Enforces New Compliance Standards for Medical Device Manufacturers and Importers
On September 6, 2024, Thai FDA released and amended the “Ministry of Public Health Notification, Re: Standards of Medical Devices that Manufacturers or Importers must comply with, B.E. 2563 (2020)”
The
Thai FDA issues guidelines on referencing existing documents, document transfer, and other cases for manufacturing and importing licensed and notified medical devices without agency evaluation
On September 19, 2024, Thai FDA releases the guidelines for submitting applications to manufacture and import Licensed and Notified Medical Devices on the condition that referencing existing documents, document transfer,
Singapore HSA Implements Testing of Diethylene Glycol and Ethylene Glycol for Health Supplement and Traditional Medicines
Following World Health Organization (WHO) Alert regarding identified batches of falsified and fraudulently mislabelled drums of DOW USP/EP Propylene Glycol, which were found to contain unacceptable levels of ethylene glycol,
Malaysia NPRA updates on Procedure and Criteria for Extending the Validity Period of the Bioequivalence Study Center (BE) and Ethics Committee registered with Drug Control Authority (DCA)
Based on current guidelines of BE study center inspections, BE study centers that have been inspected with satisfactory inspection results will be listed in NPRA BE Study Center Compliance Program
Singapore HSA Releases eCTD Specification Package for Implementation
“Singapore HSA’s Therapeutic Product Branch (TPB) is pleased to announce the release of the SG-HSA Specification version 1.0 package, effective 25 September 2024. The eCTD Specification package version 1.0 is
Singapore HSA Updates Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & CTGTP
“On 7th Oct 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene Therapy Products. The changes are summarised as below:
– Removed fax
Singapore HSA Updates Guidance Documents for CTGTP
In September/October 2024, HSA has re-organized and updated Cell, Tissue or Gene Therapy Product (CTGTP) guidance on Product Notification, Product Registration and Variation Application.
To view the updated guidance, please visit